Avedana Hemorrhoidal
NDC Package 43749-430-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Avedana Hemorrhoidal is directions: Adults-when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Marketed by Unipack Llc, this product is identified by NDC 43749-430 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
43749-430-12
Package Description
2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK (43749-430-13)
Product Code
43749-430
11-Digit Billing Format
43749043012
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 1438497 - cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository
  • RxCUI: 1438497 - cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository

Clinical Specifications

Proprietary Name
Avedana Hemorrhoidal
Dosage Form
-
Usage Information
Directions: Adults-when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.-detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:-hold suppository with rounded end up-as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"-slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose from wrapper-insert on suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement-children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Unipack Llc
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-18-2014
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43749-430). Click a package code to view its specific billing and regulatory data.

43749-430-24
4 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK (43749-430-25)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43749-430-12 identifies a specific commercial package of 2 blister pack in 1 carton / 6 suppository in 1 blister pack (43749-430-13) of Avedana Hemorrhoidal, labeled by Unipack Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Unipack Llc on September 18, 2014. The current certification is valid through December 31, 2025.

How is this Unipack Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43749043012. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
43749-430-12
11-Digit CMS (5-4-2)
43749-0430-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.